New rules for defining the classification of medical devices released – effective 1 September

New rules for defining the classification of medical devices released – effective 1 SeptemberNews from the NMPA website on 11 May:

In order to further standardize the classification and definition of medical device products, combined with the actual situation of medical device product classification and definition in China, the National Medical Products Administration organized the revision of the Announcement on Standardizing the Classification of Medical Device Products issued by the former General Office of the Food and Drug Administration (Food and Drug Administration [2017] No. 127), and issued the Announcement on Standardizing the Classification and Definition of Medical Device Products (hereinafter referred to as the “Announcement”).

The Announcement shall come into effect on September 1, 2024, and the Announcement on Standardizing the Classification of Medical Device Products issued by the former General Office of the National Food and Drug Administration (Food and Drug Administration [2017] No. 127, hereinafter referred to as No. 127) shall be simultaneously abolished.

Content Overview

The Announcement is divided into three parts:

The first part clarifies the positioning of classification and definition work, the purpose and basis for carrying out classification work, and the responsibilities of all parties involved in classification work.

The second part stipulates the principle requirements for classification and definition work in other situations such as product filing, product registration application acceptance, technical evaluation, regulatory inspection, emergency needs for public health emergencies, combination of pharmaceutical and mechanical products, innovative medical devices, etc.

The third part stipulates the principle requirements for the construction of classification informatization, guidance for the classification and definition work of provincial drug supervision and management departments, refinement of classification guidance principles, and dynamic adjustment of classification catalogs.

Compared with Document No. 127, the Announcement has mainly adjusted the following content:

Further clarification of the positioning of the categorisation process and the responsibilities of the parties involved

The Announcement stipulates that “drug regulatory authorities shall provide medical device classification and definition services to medical device registration Applicants, filers, etc.”, clearly defining classification as a service item, and further improving the responsibilities of medical device classification and definition Applicants (hereinafter referred to as Applicants), provincial drug regulatory authorities, the Medical Device Standard Management Center of the National Medical Products Administration (hereinafter referred to as the Device Standard Management Center), the Medical Device Technical Evaluation Center (hereinafter referred to as the Device Review Center), the Medical Device Classification Technical Committee, etc. in the work of medical device classification and definition, and strengthening the main responsibility of Applicants.

 Further refinement of the categorisation and definition of application routes and processes

Firstly, based on the Regulations on the Supervision and Administration of Medical Devices and the actual work of daily classification and definition, the application channels for the classification and definition of newly developed medical devices should be established. For the application for classification and definition of newly developed medical device products, it shall be uniformly reported to the Device Standards Management Center; For medical device classification and definition applications with questionable management categories, the current process shall be followed; Domestic products shall be reported to the provincial-level drug regulatory department where they are located. If the provincial-level drug regulatory department is unable to determine the category, they shall be reported to the Device Standardization Center. Imported and Hong Kong, Macao, and Taiwan products shall be reported to the Device Standardization Center. The requirement for one-time correction of application materials and the corresponding time limit should be made clear to improve work efficiency.

The second is to establish a special situation classification and definition procedure for situations such as inspection and case handling, petition reporting, etc., to better adapt to practical work needs.

The third is to clearly establish and improve a classified communication and coordination mechanism. The Device Standard Management Center establishes a communication and coordination mechanism for the classification of medical devices with the Device Audit Center and the provincial drug supervision and administration departments. For products required for emergency response to public health emergencies that are not included in the classification directory, and for which the Applicant, regulatory department, and technical evaluation department have not reached a consensus on the management category, the regulatory department can provide feedback to the Device Standards Management Center through a classification communication and coordination mechanism. The Device Standards Management Center can quickly study, define the product management attributes and management categories, and provide feedback. For products that have doubts about the management category during the technical review stage after acceptance, the management category of the product will be determined through the communication and coordination mechanism of medical device classification.

 Standardizing classification and define the requirements for application materials

One is to cancel the requirement for paper materials in the application for classification and definition, and achieve the full electronic process of online acceptance, processing, and notification of medical device classification and definition applications.

The second is to refine the requirements for classification and definition of application materials, and further clarify the submission requirements for product technical requirements, proposed product manuals, product photos or videos, conformity statements, supporting documents, and other materials that should be included in the classification and definition application materials.

 Thirdly, improve the requirements for filling in the Application Form for Classification and Definition of Medical Devices. To summarise the common problems in the daily work of classification and definition, summarise the technical characteristics of various types of products and the key points of classification and definition audit, and explain the specific expression method and the form of provision of the intended use, structural composition, working principle, state of use, material characteristics, product risk points, and description of the situation of the similar products both inside and outside the country in the Application Form for Classification and Definition of Medical Devices.

Strengthening supervision of classification implementation

 One is to strengthen supervision and guidance on classification and definition work. The Device Standardization Center strengthens guidance on the classification management work of provincial drug supervision and management departments. If necessary, it can organize spot checks on the classification and definition results replied by provincial drug supervision and management departments. For those with inaccurate responses or inconsistent classification and definition opinions, guidance and supervision will be provided for correction. For regulatory hotspots, common issues, and urgent issues, the Device Standards Control Center should study and refine the guiding principles for classification and definition within the framework of classification rules, and unify the principles and scales for product classification and definition in relevant fields.

The second is to clarify the effectiveness of the classification and definition results and the disclosure of classification and definition information. The Announcement clearly states that the product classification and definition results notified by the medical device classification and definition information system are only for use when applying for medical device registration or filing; If the relevant content in the registered or filed product information (such as main raw materials, production process, working principle, structural composition, usage method, contact parts and contact time, expected purpose, etc.) is inconsistent with the classification definition application information or classification definition application Announcement, the classification definition result is not applicable. The Device Standard Management Center shall sort and summarize the classification and definition results, as well as other relevant information related to classification, extract and organize classification and definition information, and publish it regularly; The relevant product classification and definition information is based on the information provided by the applicant and serves as an important guide for the registration and filing process of medical device products, and does not represent recognition of the expected use or safety and effectiveness of the product; The product description and expected use in the classification and definition information are used to determine the management attributes and categories of the product, and do not represent a complete expression of the relevant product registration or filing content.

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Source：NMPA

Translated & edited： Bradyknow